Maintenance treatment with rucaparib for recurrent ovarian carcinoma in ARIEL3, a randomized phase 3 trial: The effects of best response to last platinum-based regimen and disease at baseline on efficacy and safety
Authors
Oaknin, A.Oza, A. M.
Lorusso, D.
Aghajanian, C.
Dean, A.
Colombo, N.
Weberpals, J. I.
Clamp, Andrew R
Scambia, G.
Leary, A.
Holloway, R. W.
Amenedo Gancedo, M.
Fong, P. C.
Goh, J. C.
O'Malley, D. M.
Armstrong, D. K.
Banerjee, S.
Garcia-Donas, J
Swisher, E. M.
Cameron, T.
Maloney, L.
Goble, S.
Ledermann, J. A.
Coleman, R. L.
Affiliation
Gynaecologic Cancer Programme, Vall d'Hebron Institute of Oncology (VHIO), Hospital Universitari Vall d'Hebron, Vall d'Hebron Barcelona Hospital Campus, Barcelona, SpainIssue Date
2021
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Background: The efficacy and safety of rucaparib maintenance treatment in ARIEL3 were evaluated in subgroups based on best response to most recent platinum-based chemotherapy and baseline disease. Methods: Patients were randomized 2:1 to receive either oral rucaparib at a dosage of 600 mg twice daily or placebo. Investigator-assessed PFS was assessed in prespecified, nested cohorts: BRCA-mutated, homologous recombination deficient (HRD; BRCA mutated or wild-type BRCA/high loss of heterozygosity), and the intent-to-treat (ITT) population. Results: Median PFS for patients in the ITT population with a complete response to most recent platinum-based chemotherapy was 11.1 months in the rucaparib arm (126 patients) versus 5.6 months in the placebo arm (64 patients) (HR, 0.33 [95% CI, 0.23-0.48]), and in patients with a partial response (249 vs. 125), it was 9.0 versus 5.3 months (HR, 0.38 [0.30-0.49]). In subgroups of the ITT population based on baseline disease, median PFS was 8.2 versus 5.3 months (HR, 0.40 [0.28-0.57]) in patients with measurable disease (141 rucaparib vs. 66 placebo), 10.4 versus 4.5 months (HR, 0.31 [0.20-0.48]) in those with nonmeasurable but evaluable disease (104 vs. 56), and 14.1 versus 7.3 months (HR, 0.35 [0.24-0.51]) in those with no residual disease (130 vs. 67). Across subgroups, significantly longer median PFS was observed with rucaparib versus placebo in the BRCA-mutated and HRD cohorts. Objective responses were reported in patients with measurable disease and in patients with nonmeasurable but evaluable baseline disease. Safety was consistent across subgroups. Conclusion: Rucaparib maintenance treatment provided clinically meaningful efficacy benefits across subgroups based on response to last platinum-based chemotherapy or baseline disease.Citation
Oaknin A, Oza AM, Lorusso D, Aghajanian C, Dean A, Colombo N, et al. Maintenance treatment with rucaparib for recurrent ovarian carcinoma in ARIEL3, a randomized phase 3 trial: The effects of best response to last platinum?based regimen and disease at baseline on efficacy and safety. Vol. 10, Cancer Medicine. Wiley; 2021. p. 7162�73.Journal
Cancer MedicineDOI
10.1002/cam4.4260PubMed ID
34549539Additional Links
https://dx.doi.org/10.1002/cam4.4260Type
ArticleLanguage
enae974a485f413a2113503eed53cd6c53
10.1002/cam4.4260
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